Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M), MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1), TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
FLUOCINOLONE ACETONIDE 0.01% / MINOXIDIL 5% / TRETINOIN 0.025%- FLUOCINOLONE ACETONIDE 0.01% / MINOXIDIL 5% / TRETINOIN 0.025% SOLUTION SINCERUS FLORIDA, LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- DIRECTIONS FOR USE SINCERUS FLORIDA, LLC. ADVERSE REACTIONS ACTIVE, INACTIVE NDC 72934-4079-8. FLUOCINOLONE ACETONIDE USP 0.01% / MINOXIDIL USP 5% / TRETINOIN USP 0.025%. SOLUTION 60 GM Sincerus Florida, LLC FLUOCINOLONE ACETONIDE 0.01% / MINOXIDIL 5% / TRETINOIN 0.025% fluocinolone acetonide 0.01% / minoxidil 5% / tretinoin 0.025% solution PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-40 79 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH FLUO CINO LO NE ACETO NIDE (UNII: 0 CD5FD6 S2M) (FLUOCINOLONE ACETONIDE - UNII:0 CD5FD6 S2M) FLUOCINOLONE ACETONIDE 0 .0 1 g in 10 0 g MINO XIDIL (UNII: 59 6 5120 SH1) (MINOXIDIL - UNII:59 6 5120 SH1) MINOXIDIL 5 g in 10 0 g TRETINO IN (UNII: 56 8 8 UTC0 1R) (TRETINOIN - UNII:56 8 8 UTC0 1R) TRETINOIN 0 .0 25 g in 10 0 g PRODUCT CHARACTERISTICS COLOR ye llo w S CORE S HAP E S IZ E FLAVOR IMPRINT CODE CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:729 34-40 79 - 8 6 0 g in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n Pro duc t 0 5/0 9 /20 19 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE unappro ved drug o ther 0 5/0 9 /20 19 LABELER - Sincerus Florida, LLC (080105003) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Sincerus Flo rida, LLC 0 8 0 10 50 0 3 ma nufa c ture (729 34-40 79 ) Revised: 5/2019 Đọc toàn bộ tài liệu